This website is dedicated to providing public information regarding DePuy Hip recall and other related information to the recall. None of the information on this site is intended to be formal legal or medical advice, nor should any information on this site be construed as advice that should be used in lieu of information from your attorney or physician.

Saturday, January 26, 2013

Johnson & Johnson Hip Flop

The Economist
JOHNSON & JOHNSON is one of America’s best known companies and the world’s biggest seller of medical products. Every drug and device business has publicity problems from time to time. J&J is the market leader. Recent years brought recalls, and more recalls, of popular over-the-counter products. Some had too much active ingredient, others smelled odd, yet others had metal shavings. The worst news concerned its ASR hips. The metal implants had the unfortunate habit of shedding debris inside patients. In August 2010 DePuy, a J&J subsidiary, recalled 93,000 ASR hips. The company is now trying to move forward, but the news may grow worse.

J&J faces more than 10,000 lawsuits over its ASR hips, according to a quarterly filing in November. Lawsuits often bring settlements (Reuters reports that J&J’s may be particularly pricey), but they occasionally also bring trials. And trials often bring embarrassment, then bigger settlements or bigger awards. On January 25th an ASR suit will go to court in California. Already, court documents reveal worrying new details. In 2011 an internal study showed that 37% of ASR hips failed within five years. And in 2008, two years before the recall, there was already some evidence of problems with the hips.

These documents follow others, unearthed by the New York Times last year, which suggest safety concerns in 2009. In August of that year America’s Food and Drug Administration (FDA) wrote to DePuy about an application for a modified ASR product (a partial rather than complete hip replacement). The FDA said the indication was “not approvable”, in part because “there appear to be some publicly available data on the ASR that suggest somewhat poorer results for the device than results suggested by the data you submitted”. The letter also pointed to several analyses of patients with ASR hips, noting that the “high concentration of metal ions observed in some of these patients is concerning.”

For those wondering how the ASRs ever got on the American market in the first place—American regulators are supposed to be the world’s toughest—a recent paper in the New England Journal of Medicine provides a helpful history. For the most risky products, such as implanted defibrillators, companies must present clinical data. But many devices require only a so-called 510(k) application that shows them to be of “substantial equivalence” to a device already on the market. The FDA approved the ASR through this channel. (The later ASR product, which was never approved in America, had to meet the harder test.) On January 18th the FDA proposed regulations to require more stringent review for metal-on-metal hips. For those who have replaced their hip replacements, it may feel a bit late.